News from the FDA

In what could be a new chapter in the debate over direct-to-consumer (DTC) genetic testing, 23andMe announced that it delivered a first round of 510(k) documentation to FDA. The company submitted seven out of its portfolio of some 200 genetic test reports.

The submission to FDA amounts to a reversal of the company's past argument that its DTC testing service was purely informational and should not be regulated as medical testing. As DTC genetic testing grew in the late 2000s, FDA in 2010 became wary of the industry, sending warning letters to 23andMe and several other companies accusing them of marketing medical devices without FDA clearance. At the same time the agency issued warning letters to DTC genetic testing companies, it held a public meeting of its Molecular and Clinical Genetics Advisory Committee, which expressed concerns about DTC genetic testing. The panel did not vote on whether FDA should allow these companies to continue marketing DTC genetic tests without FDA clearance, but strongly warned that many of the tests could only be useful when interpreted by a physician.

A highly visible pioneer in the DTC genetic testing market, 23andMe was the only company that continued to sell its testing services after the spate of FDA warning letters. In a CLN interview after the 2010 public meeting, Alberto Gutierrez, PhD, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, indicated that the agency would work with DTC companies on a case-by-case basis, and would not require them to withdraw DTC tests from the market if the company worked with the agency towards official FDA clearance.

FDA Clears Vitamin D Test

Roche received FDA clearance for its fully automated Eclesys Vitamin D assay for assessment of vitamin D2 and D3 sufficiency in adults. Using Roche's proprietary electrochemiluminescence technology, the assay measures a broad range of vitamin D levels with high precision at the low end of detection. This capability makes it effective for evaluating severely deficient patients. The assay runs on Roche's cobas modular platforms, and along with the company's array of bone metabolism tests, can help guide physicians in their treatment of patients with vitamin D deficiency.

FDA Approves Erbitux Co-Diagnostic

QIAGEN announced FDA approval for the company's therascreen KRAS RGQ PCR Kit, a genetic co-diagnostic intended for determining whether the drug Erbitux is an appropriate treatment for patients with metastasized colorectal cancer (CRC). Erbitux works by binding to the epidermal growth factor receptor on the surface of CRC cells, thereby blocking a signal that leads to their growth. However, CRC cells with a mutated KRAS gene fail to respond to Erbitux. The test screens for seven different KRAS mutations in order to identify patients for whom Erbitux treatment would be ineffective.